Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer

Part of paid clinical trials in Sacramento, California.

Sponsor
Radiation Therapy Oncology Group
Study ID
NCT00081289
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation Therapy — RADIATION
    Pelvic radiation therapy given once daily 5 days a week for 6 weeks, 45 Gy in 25 fractions + boost of 5.4 Gy in 3 fractions for a total dose of 50.4 Gy.
  • Capecitabine 1650 mg/m^2/day — DRUG
    825 mg/m\^2 q12 hours (1650 mg/m\^2/day) orally 5 days per week during radiotherapy.
  • Capecitabine 1200 mg/m^2/day — DRUG
    600 mg/m\^2 q12 hours(1200 mg/m\^2/day) orally 5 days per week during radiotherapy.
  • Irinotecan — DRUG
    50mg/m\^2 IV over 1 hour on days 1, 8, 22, and 29
  • Oxaliplatin — DRUG
    50mg/m\^2 IV over 2 hours on days 1, 8, 15, 22, and 29
  • Surgery — PROCEDURE
    All patients will undergo surgery four to eight weeks following the completion of radiation therapy. The choice of procedure abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis is at the discretion of the surgeon.
  • Folinic Acid — DRUG
    400 mg/m\^2 IV over 2 hours Day 1 (postoperatively) ,every 14 days, for nine 14-day cycles.
  • Fluorouracil — DRUG
    5-fluorouracil bolus 400 mg/m\^2 IV push Day 1 (postoperatively), every 14 days, for nine 14-day cycles. 5-fluorouracil infusion 2400 mg/m\^2 IV continuous infusion over 46 hours, beginning day 1, every 14 days, for nine 14-day cycles.
  • Oxaliplatin — DRUG
    85 mg/m\^2 IV over 2 hours Day 1 (postoperatively), every 14 days, for nine 14-day cycles.

Study Details

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.

Key Dates

Start date
Mar 31, 2004
Status verified
Feb 2020
Primary completion
May 31, 2011
Completion
Dec 31, 2016

Study Design

Enrollment
146 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant chemoradiation with irinotecan
    Patients receive neoadjuvant therapy comprising 45 Gy (1.8 Gy/fx) + 5.4 Gy boost (1.8 Gy/fx) radiation therapy (RT), oral capecitabine 1200mg/m\^2/day 5 days/week during RT, and irinotecan 50 mg/m\^2 IV for 1 hour days 1, 8, 22, 29. Surgery 4-8 weeks after RT. Postoperative chemotherapy beginning Day 1 postoperatively for nine 14-day cycles(folinic acid 400 mg/m\^2 over 2 hours Day 1; 5-fluorouracil bolus 400 mg/m\^2 IV push Day 1 plus 2400 mg/m\^2 IV continuous infusion over 46 hours, beginning Day 1; and oxaliplatin 85 mg/m\^2 IV over 2 hours Day 1) .
  • Experimental: Neoadjuvant chemoradiation with oxaliplatin
    Patients receive neoadjuvant therapy comprising 45 Gy (1.8 Gy/fx) + 5.4 Gy boost (1.8 Gy/fx) radiation therapy (RT), oral capecitabine 1650mg/m\^2/day 5 days/week during RT, and oxaliplatin 50 mg/m\^2 IV for 2 hours days 1, 8, 15, 22, 29. Surgery 4-8 weeks after RT. Postoperative chemotherapy beginning Day 1 postoperatively for nine 14-day cycles(folinic acid 400 mg/m\^2 over 2 hours Day 1; 5-fluorouracil bolus 400 mg/m\^2 IV push Day 1 plus 2400 mg/m\^2 IV continuous infusion over 46 hours, beginning Day 1; and oxaliplatin 85 mg/m\^2 IV over 2 hours Day 1) .

Primary Outcome Measure

Pathologic Complete Response Rate [ Time Frame: After protocol surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of California Davis Cancer CenterSacramentoCalifornia95817-
Baptist-South Miami Regional Cancer ProgramMiamiFlorida33176-
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarveyIllinois60426-
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarltonNew Jersey08053-
Northeast Radiation Oncology CenterDunmorePennsylvania18512-

Find similar trials in Sacramento, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of California Davis Cancer Center· Sacramento, CABaptist-South Miami Regional Cancer Program· Miami, FLIngalls Cancer Care Center at Ingalls Memorial Hospital· Harvey, ILFox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton· Marlton, NJNortheast Radiation Oncology Center· Dunmore, PA

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